InspireMD Inc.

Please stand by, your program is about to begin. Good day, everyone, and welcome to the InspireMD third quarter 2024 earnings call. Currently, all participants are in a listen-only mode. Later, you will have the opportunity to ask questions during the question and answer session. You may register to ask questions by pressing the star and one on your telephone keypad. You may withdraw your question by pressing star two. Please note, this conference is being recorded. I will now turn the conference over to Chuck Padala with LifeSci Advisors. Thank you. You may begin.

Thank you, Operator, and good morning, everyone. Thank you for joining us for the InspireMD Third Quarter Financial Results and Corporate Update Conference Call. Joining us today from InspireMD are Marvin Slossman, Chief Executive Officer, and Craig Chor, Chief Financial Officer. Shane Gleason, Chief Commercial Officer, will also be available for Q&A. During this call, management will be making forward-looking statements, not historical facts, which are based upon management's current expectations, beliefs, and projections, many of which, by their nature, are inherently uncertain. These forward-looking statements involve risks and uncertainties that may cause actual results to differ materially from those expressed in such forward-looking statements. For more information about these risks, please refer to the risk factors described in InspireMD's most recently filed periodic reports on Forum 10-K and Forum 10-Q for any updates in our corporate reports on Forum 8-K filed with the U.S. Security and Exchange Commission and InspireMD's press release that accompanies this call, particularly the cautionary statements made in it. This call contains time-sensitive information that is accurate only as of today, November 12th, 2024. Except as required by law, InspireMD disclaims any obligation to publicly update or revise any information to reflect events or circumstances that occur after this call. It is now my pleasure to turn the call over to Marvin Slossman, Chief Executive Officer. Marvin, please go ahead.

Thank you, Chuck, and thanks to everyone for joining the call this morning. I'd like to begin with a review of our very strong Q3 financial results. We reported total C-Guard revenue of $1.81 million, representing growth of more than 16% over the third quarter of last year. Our results were driven by sales of over 3,100 C-Guard implants during the quarter, representing growth of nearly 14% over the same period last year. To the benefit of thousands of patients in our end markets, suffering from carotid artery disease. We're particularly proud of these results, which demonstrate consistent quarter-over-quarter growth and solidify our strong commercial foundation with more than 60,000 implants sold to date. Our stent technology has now captured double-digit market share across 30 countries, where we have enabled providers and patients to benefit from our best-in-class carotid stent with leading clinical outcomes. As we approach the potential approval and launch of Seaguard Prime in the U.S., which we anticipate in the first half of 2025, we would once again like to offer a measure of how our global Q3 sales would have translated to U.S. revenue. We sold 3,129 implants in international markets during the quarter. If instead sold in the U.S., these units would have generated over $14 million in revenue assuming an equal mix of CAS and TCAR sales at current U.S. market ASPs. To put our global sales volume in further perspective, the current U.S. TCAR market leader reported about $49 million in revenue on 6,700 procedures last quarter. So in terms of global patients treated, our devices are already reaching nearly half the number of patients as the TCAR market leader. and we have not even entered the U.S. market yet. We continue to believe that our entry into the U.S. market, along with the future introduction of our switchguard neuroprotection system for TCAR procedures, positions our business for significant revenue growth once cleared. As we look to 2025, we will continue investing in the U.S. market with intention to drive significant growth in both sales and margins, while establishing a new standard in carotid revascularization in both Cas and TCAR versions once approved. While staying on the topic of the U.S. opportunity, during the third quarter, we submitted our PMA premarket approval application to the FDA. We utilized a modular submission approach to facilitate an efficient review by the agency And with our submission now complete, we look forward to a timely decision which, if positive, would enable our U.S. market launch of C-Guard Prime for the treatment of carotid artery disease and stroke prevention. Recall that our regulatory submission was based on the overwhelmingly positive one-year data from our C-Guardians clinical trial presented at the Leipzig Interventional Course earlier this year. The C-Guardians clinical trial evaluated the safety and efficacy of C-Guard for the treatment of carotid artery stenosis and enrolled 316 patients across 24 trial sites in the U.S. and Europe. The results showed a primary endpoint of a major adverse event rate of 1.95% through 12 months post-procedure, which is the lowest such event rate reported for any carotid stent or embolic protection device to date. We received notification from the FDA that our PMA submission was accepted, effective September 15th, which then triggered a 180-day review period. Therefore, we anticipated decision in early 2025, and we are prepared to aggressively execute on a robust commercial and operational launch plan if approved. As a reminder, receipt of the premarket approval from FDA next year would trigger the second of four milestone-based financing tranches pursuant to the transformational private placement of up to $113.6 million that we announced in May 2023. If fully exercised, the second tranche would raise an additional $17.9 million in gross proceeds for the company, which, like the first tranche, triggered this past July upon the presentation of Positive Sea Guardian's pivotal data. We're very grateful to the highly regarded institutional investors who continue to show their support for our company and our vision, including Marshall Waste, Orgamed, Rosalyn, Nanahala, Solius, Velen, as well as members of our boards of directors. After premarket approval, the remaining two milestones, which would trigger additional tranche financings, include receipt of FDA clearance for SwitchGuard T-car kit to include our Seaguard Prime stent, and the completion of four quarters of commercial sales of SeaGuard in the United States, which we anticipate in the back half of 2026, pending the approvals I mentioned earlier and based on our current plans. In parallel with the submission of our modular PMA, we've continued to build out what I consider to be a world-class commercial and operational engine to support our pending U.S. launch. Today, I'm especially pleased to share that we have strengthened our positioning by executing a seamless transition to a new world-class headquarters facility in Miami, Florida, from which we are reporting today. This new facility ideally positions us to support the anticipated U.S. launch and commercialization of C-Guard Prime. South Florida has a rich history in medical device innovation and therefore provides us access to top-tier talent and other resources that support the ongoing build-out of field sales, clinical support, and operational teams supporting infrastructure all of which are ongoing. With our U.S. base now established, we're prepared to continue to build on our success outside of the U.S. while contingent upon approval, fully serving the strong U.S. demand we anticipate for SeaGuard Prime and SwitchGuard neuroprotection system. Turning now to our pipeline, last month we announced that the FDA approved our investigational device exemption application to initiate the C-Guardians 2 pivotal study for our C-Guard Prime TCAR-indicated carotid stent system, specifically developed for use during TCAR procedures. This represents a significant step forward toward an offering of a complete TCAR tool set with next-generation enhancements, including the best-performing implant and C-Guard Primes. As a reminder, the Switch Gardener Protection TCAR platform is designed to prevent embolic debris generated during a carotid stenting procedure from traveling to the brain, passing the blood through an integrated filter, and returning it to the patient in a closed circuit to minimize blood loss during the procedure. With input and support from the world's top vascular surgeons performing TCAR procedures, we've developed a next-generation toolset of TCAR features and accessories which once cleared will provide next level TCAR performance combined with Best Carotid Implant and C-Guard Prime. As we've said before, our ongoing investment in both CAS and TCAR products and programs was intended to address the broadest physician-based performing carotid revascularization and was done anticipating a time when product innovation and procedural reimbursement further shifted the tides toward an endovascular first standard of care. Turning now to our market growth initiatives, we previously announced that we entered into a strategic agreement with the Jacobs Institute at the State University of New York at Buffalo and Dr. Adnan Siddiqui, Vice Chairman and Professor of Neurosurgery, to conduct an early feasibility study of C-Guard Prime for severe carotid stenosis or occlusion in conjunction with thrombectomy in patients presenting with acute ischemic stroke and tandem lesions. As a reminder, C-Guard Prime, with its proprietary Micronet mesh, It's designed to provide superior embolic prevention during the carotid artery stenting procedure, and we believe this study will demonstrate safety and feasibility of using our stent in these acute stroke procedures. Our investment in this study reflects our strong commitment to the neuro community and represents a critical component of our long-term growth strategy. We anticipate that the first patient will be enrolled imminently. At this point, I'd like to turn the call over to Craig to review the financials. Craig?